Surgery is conventionally performed while a patient is lying in a supine position. Increasingly, surgical procedures (and other medical procedures) require patients to be unconscious and in upright, sideways, or upside down positions, or in some other non-horizontal position. For example, it is preferred for patients to be in an upright position during breast augmentation surgery so that the surgeon can see the full effects of gravity on a patient's breasts for optimum results. However, having the patient in an upright position causes the patient's head and neck to drop forward or sideways by force of gravity. This can lead to soreness and strain on the neck, shoulder, and/or spine region, post-surgery. Clinical documentation of complaints of such soreness resulting from a non-stabilized head during such procedures is increasing. See Hindman B, Palecek J, Posner K, Traynelis V, Lee L, Sawin P, Tredway T, Todd M, Domino K: Cervical Spinal Cord, Root, and Bony Spine Injuries, A Closed Claims Analysis. Anesthesiology 2011; 114:782-95; Lanier W, Warner M: New Perioperative Cervical Injury, Medical and Legal Implications of Patients and Anesthesia Providers. Anesthesiology 2011; 114:729-31; Dippmann C, Winge S, Nielsen H: Severe Cerebral Desaturation During Shoulder Arthroscopy in the Beach-Chair Position. Arthroscopy: The Journal of Arthroscopic and Related Surgery 2010, V26, No. 29, pp. S148-S150; Lee M, Cassinelli E, Riew K: Prevalence of Cervical Spine Stenosis, Anatomic Study in Cadavers. The Journal of Bone & Joint Surgery 2007, V89-A, No. 2, pp. 376-80; and Wilder B: Hypothesis: The Etiology of Midcervical Quadriplegia after Operation with the Patient in the Sitting Position, Neurosurgery 1982, V11, No. 4, pp. 530-31; (6) Pohl A, Cullen D: Cerebral ischemia during shoulder surgery in the upright position: a case series, Journal of Clinical Anesthesia 2005, V17, 463-469, incorporated herein by reference.
Allowing a patient's head to drop forward or sideways can also lead to unintended neck, shoulder, and spinal injuries. These injuries can be exacerbated during surgeries because unconscious (or heavily sedated) patients cannot protect themselves through reflexes or otherwise.
In the past, many cervical spine stabilization devices or techniques have been developed. Cervical spine stabilization devices arise from a spectrum of applications. On one end of the spectrum, neurosurgeons use Halo devices to stabilize the head and neck. However, some of these Halo devices use aggressive screws (pins) that are placed into the human skull.
On another end of the spectrum, physicians have used towels or pillows on either side of the cervical spine; often combined with some type of tape (duct tape or medical tape) to hold the “home made” apparatus together.
The most well-known cervical spine stabilization device is a standard neck brace (for example, the Aspen Collar). These are used by ambulances at the scene of an accident. They are also used in hospitals to maintain a safe neck position for patients who are at risk for cervical injury. The Aspen Collar, or equivalent collar, is used widely across the United States. However, collars are undesirable to use during surgery because they cover the front of the neck. This prevents surgeons from gaining access to the neck during surgical procedures. It also prevents anesthesiologists from having full access to the neck and airway during intubation for surgery.
Accordingly, it is an object of the present invention to provide a head stabilization device that can immobilize a patient's head while the patient is unconscious (or heavily sedated) and positioned on an operating table (or some other apparatus or surface) in an upright, sideways (tilted to the side), or upside down position, or in any other non-horizontal position, to reduce or eliminate soreness, strain, and/or injury to the neck, shoulder, or spine during surgery (or other medical procedure).
It is also an object of the present invention to provide a device that keeps the head, neck, and shoulders in the same relative positions, even with changes in position of an operating table, chair or some other apparatus.
It is another object of the present invention to provide a device that allows surgeons to have access the front of the neck during surgeries, and allows anesthesiologists to have full access to a patient's airway and neck during intubation for surgery.
It is a further object of the present invention to provide an inexpensive device that can be used for temporary prophylactic (preventative) use to prevent injury in a medical setting (for example, to prevent a patient's head from dropping forward when that patient is placed in an upright position during breast surgery).
It is still a further object of the present invention to provide a user-friendly device that utilizes simple straps, in contrast to invasive pins that are used in Halo devices or bulky pieces that must be secured together (such as in the Aspen Collar).